Policies

• Doubling Farmers’ Income: Rationale, Strategy, Prospects and Action plan, NITI Policy Paper No. 1/2017 Download here

• Twelfth Five Year Plan (2012–2017): Economic Sectors, 2013 Download here

• National Biotechnology Development Strategy 2015-2020 Download here

• National Policy for Farmers, 2007 Download here

• National Environment Policy, 2006 National Environment Policy

• Drug Policy, 2002 Download here

• National Seeds Policy, 2002 Download here

Guidelines and Protocols

NATIONAL

• _{Entry of Banana Bract Mosaic Virus in “List of Infective Microorganisms corresponding to different Risk Groups, 2021" superseding the Annexure I of "Regulations & GuideIines for Recombinant DNA Research and Biocontainment, 2017. Download here}

• _{Entry of Hansenula polymorpha in “List of Infective Microorganisms corresponding to different Risk Groups, 2021" superseding the Annexure I of "Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017". Download here}

• Entry of Tomato Leaf Curl New Delhi Virus in  “List of Infective Microorganisms corresponding to different Risk Groups, 2021" superseding the Annexure I of "Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017". Download here

•  Entry of Pseudorabies virus in “List of Infective Microorganisms corresponding to different Risk Groups, 2021" superseding the Annexure I of "Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017  Download here

• Standard Operating Procedures for Regulatory Review of Genome Edited Plants under SDN-1 and SDN-2 Categories. Download here

• Guidelines for the Safety Assessment of the Genome Edited Plants, 2022  Download here

• List of infective Microorganisms corresponding to different Risk Groups, 2021" vide DBT OM dated 09.12.2021 Download here

• Minimum qualification of Biosafety Officer, vide DBT OM dated 12.08.2021 Download here

• Submission of Documents for Compliance on IBKP vide DBT OM dated 11.08.2021, Download here

• SOPs for exchange of infectious biosamples/biospecimen from Biorepsitory, 2021 vide DBT OM dated 07.06.2021 Download here

• Generic PCT protocol for assessing toxicity of recombinant DNA derived products in animal models. Download here

• Guidelines for the Establishment of Containment Facilities: BSL2 and BSL3 and Certification of BSL3 facility 2020,vide DBT order dated 18.12.2020 Download here

• Online IBSC meetings conditions, vide DBT OM dated 22.12.2020 Download here

• Handbook for Institutional Biosafety Committees (IBSCs), Third Revised Edition, September 2020 Download here

• Streamlining of the Regulation Procedure of Biopharma Drug Development, vide DBT OM dated 06.08.2020 Download here

• Rapid Response Regulatory Framework for COVID-19 Vaccine Development vide DBT OM dated 26.05.2020- Checklist recombinant vaccine Covid 19

• OM for Rapid Response Regulatory Framework for COVID-19 vide DBT OM dated 20.03.2020 Rapid Response Regulatory Framework for COVID-19

• Checklist for information requirements in the Applications and Reports on Preclinical toxicity study of similar  Biologics, Download here

• Revised Simplified Procedures/ Guidelines on Import, Export and Exchange of GE organisms and products thereof for R&D purpose, 2020 vide              DBT OM dated 17.01.2020 Revised Simplified Procedures/Guidelines on Import, Export and Exchange 

• Regulations & Guidelines for Recombinant DNA Research and Biocontainment, 2017  Download here

• Environmental Risk Assessment of Genetically Engineered Plants: A Guide for Stakeholders, 2016  Download here

• Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016 Download here

• Risk Analysis Framework, 2016   Download here     

• Guidelines on Similar Biologics, 2016 Download here

• Simplified Procedures/ Guidelines on Exchange, Import & Export of GE organisms & Products thereof for R&D purpose, 2015 Download here

• Guidelines and Handbook for Institutional Biosafety Committees (IBSCs), 2011 Download here

• Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008 Download here

• Guidelines for the monitoring of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008  Download here

• Guidelines for the conduct of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008 Download here

• Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008 Download here

• Protocol for Food and Feed Safety Assessment of GE crops, 2008 Download here

• Export control system of SCOMET items, 2018 Download here

• Monitoring Confined Field Trials of Genetically Engineered Plants- A Monitoring Manual; Monitoring Confined Field Trials of GE Plants- A monitoring Manual

• Monitoring Confined Field Trials of Genetically Engineered Plants- A Tool for trainers; Monitoring Confined Field Trial of GE Plants -Tools for Trainers

• Confined Field Trials of GE Plants, 2015; Confined Field Trials of GE Plants, 2015